Hydroxyurea for Anemia, Sickle Cell

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UPMC, Pittsburgh, PA
Anemia, Sickle Cell+2 More
Hydroxyurea - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if erythropoietin (EPO) and hydroxyurea are safe and effective in treating anemia in patients with sickle cell disease. Hydroxyurea is used to treat Anemia and Sickle Cell. This treatment is free and will not include a placebo. Hydroxyurea has been previously approved by the FDA for a different condition.

Eligible Conditions

  • Anemia, Sickle Cell

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Anemia, Sickle Cell

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Baseline to 4 weeks; Baseline to 8 weeks; Baseline to 12 weeks; Baseline to 24 weeks;

Baseline to 12 weeks
Change in hemoglobin (Hb) level
Frequency of adverse events (AEs)
Week 24
Changes in cardiopulmonary function as assessed by echocardiographic measurements
Changes in exercise capacity as assessed by 6-minute walk test with Modified Borg Dyspnea scale
Changes in health-related quality of life
Changes in hematological and hemolytic parameters
Changes in markers of organ function and erythropoiesis
Week 24
Changes in pain measured by Visual Analog Scale
Changes in pain measured using novel pain assessment tool

Trial Safety

Safety Progress

1 of 3

Other trials for Anemia, Sickle Cell

Trial Design

1 Treatment Group

Erythropoietin
1 of 1
Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Hydroxyurea · No Placebo Group · Phase 1 & 2

ErythropoietinExperimental Group · 2 Interventions: Epoetin Alfa, Hydroxyurea · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epoetin Alfa
2014
Completed Phase 4
~7810
Hydroxyurea
2006
Completed Phase 4
~3620

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 4 weeks; baseline to 8 weeks; baseline to 12 weeks; baseline to 24 weeks;
Closest Location: UPMC · Pittsburgh, PA
Photo of UPMC Hillman Cancer Center 1Photo of UPMC Hillman Cancer Center 2Photo of UPMC Hillman Cancer Center 3
2017First Recorded Clinical Trial
1 TrialsResearching Anemia, Sickle Cell
54 CompletedClinical Trials

Who is running the clinical trial?

Julia XuLead Sponsor
Carnegie Mellon UniversityOTHER
70 Previous Clinical Trials
536,441 Total Patients Enrolled
American Society of HematologyOTHER
8 Previous Clinical Trials
20,641 Total Patients Enrolled
2 Trials studying Anemia, Sickle Cell
221 Patients Enrolled for Anemia, Sickle Cell
Julia Z Xu, MD, MScGHPrincipal InvestigatorUniversity of Pittsburgh

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Transferrin saturation ≥ 20% and ferritin ≥ 100 ng/mL.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.